This document specifies the particular requirements for the basic safety and essential performance of roller-type dermal needles for single use. It applies to roller-type dermal needles that have the capacity to penetrate the skin.
It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of roller-type dermal needles.
It does not apply to tapping-type dermal needles or reusable roller-type dermal needles.
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